Kaiser Permanente Submits Citizen Petition on REMS

In yet another twist in the debate regarding FDA’s use of Risk Evaluation and Mitigation Strategies (“REMS”), Kaiser Permanente (“Kaiser”), which is the largest private integrated health care delivery system in the U.S., submitted a citizen petition on December 22, 2009 requesting FDA take several actions in order to mitigate concerns it has with FDA’s implementation of REMS, specifically Elements to Assure Safe Use (“ETASU”).

In its citizen petition, Kaiser notes that § 505-1 of the Federal Food, Drug and Cosmetic Act (“FDCA”) requires FDA to obtain input from health care providers, patients, etc. with regard to ETASU in order to ensure that a REMS is not unduly burdensome to the patient and to minimize the burden on the health care system. However, with the exception of REMS for extended-release opioids, Kaiser claims that FDA has not publicly sought input from patients or health care providers on the implementation of REMS as required by § 505-1. Kaiser further claims that REMS, especially those with ETASU, can add a significant burden to the delivery of health care and thus potentially increase the cost of REMS such that it outweighs the benefits. As a consequence, Kaiser believes that health care providers and insurers should be consulted before a new REMS with ETASU is implemented.

Kaiser discusses five actions it would like FDA to take in order to minimize the burden of ETASU on health care providers as well as ensuring that they have a voice in the implementation of REMS. First, Kaiser requests that FDA “increase transparency and opportunity for public comment in the development, implementation and assessment of REMS programs.” As such, Kaiser would like FDA to provide increased opportunity for public comment on all REMS with ETASU; however, Kaiser also envisions FDA establishing an advisory committee dedicated to the review of ETASU. In the interim, Kaiser suggests that advisory committees (with a health care provider member) reviewing drugs that will likely receive ETASU also have input on the ETASU itself. Kaiser argues that this type of input before an ETASU is implemented could reduce the likelihood that the program will need to be altered later as well as lessening the burden on the health care system.

Second, Kaiser would like FDA to make de-identified data collected through the use of ETASU publically available, which would permit health care providers, and other parties, to identify the effectiveness of REMS.

Third, Kaiser requests that FDA evaluate the effectiveness of ETASU that have been in effect for at least one year and extend that evaluation process to all ETASU on an annual basis. Kaiser argues that this will ensure that the benefits of the REMS will continue to outweigh the cost to patients and the health care provider while also ensuring its success.

Fourth, Kaiser’s citizen petition raises the issue of manufacturers using ETASU to limit access of a drug to certain health care providers. Kaiser acknowledges that an ETASU may require that some drugs only be dispensed by certified pharmacies, but it argues that manufacturers have used this requirement to prevent or limit some health care providers from using their own facilities by refusing to certify them despite the fact that these pharmacies are otherwise qualified to dispense the drug. According to the citizen petition, some manufacturers have refused to certify a Kaiser pharmacy for no reason other than the fact that the manufacturer has “contracted” with a specialty pharmacy, thus permitting manufacturers to dictate who can prescribe and dispense a drug with ETASU.

Finally, Kaiser would like FDA to ensure that REMS are implemented in a way to protect patient health information. Specifically, Kaiser expresses concern that patient enrollment forms for REMS include an authorization for disclosure of such information to third parties and some enrollment forms make receiving the drug contingent on patients accepting this. Kaiser suggests that this concern could be alleviated if manufacturers were required to identify all entities they distribute patient information to as part of the regular REMS assessments.